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New treatment option for Pancreatic Cancer Metastatic
Official title Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer
ClinicalTrials.gov ID: NCT05254171
What this study is testing
What is SBP-101?
SBP-101 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pancreatic cancer metastatic.
Also referred to as ivospemin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a randomized, double-blind, placebo-controlled, multicenter study of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in subjects previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), including subjects who have received prior neoadjuvant or adjuvant treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and...
- Life expectancy ≥ 3 months.
- Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
You likely can't join if
- When results of germline or somatic testing done prior to screening are known, people known to have mutations of the BRCA 1/2 (Breast Cancer gene)...
- Concomitant metformin administration. Diabetic people on treatment with metformin, or any other derivative thereof, must discontinue it at least 5...
- Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia [-6.0 diopters or...
- Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it...
- Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of...
- Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma.
See the full eligibility criteria
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and...
- Life expectancy ≥ 3 months.
- Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan by RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Adult, age ≥ 18 years, male or female.
- Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception from 2 weeks before the first administration...
- Adequate bone marrow, hepatic and renal function as outlined in protocol.
- QTc interval ≤ 470 ms (for women) and ≤ 450 ms (for men) on the ECG at baseline calculated by either the Fridericia or Framingham formula.
- Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required.
- When results of germline or somatic testing done prior to screening are known, people known to have mutations of the BRCA 1/2 (Breast Cancer gene) are excluded.
- Concomitant metformin administration. Diabetic people on treatment with metformin, or any other derivative thereof, must discontinue it at least 5 days prior to C1D1 and not take metformin while on study (other diabetic...
- Any history of retinopathy or at risk for retinal detachment (personal or family history of retinal detachment, extreme myopia [-6.0 diopters or approximately 20/500], eye surgery \<6 months prior to C1D1, or history of...
- Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would...
- Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance.
- Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma.
- Symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic people without history of CNS metastases is not required.
- Serum albumin \< 30 g/L (3.0 g/dL).
- Deep vein thrombosis (DVT) or portal vein occlusion, pulmonary embolism (PE), or other thromboembolic event that occurs during screening.
- Presence of known active bacterial, fungal, or viral infection requiring systemic therapy.
- Known active infection with human immunodeficiency virus (HIV), hepatitis B or C.
- Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction.
- Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV.
- Pregnant or lactating.
- Major surgery within 4 weeks prior to the start of study drug treatment, without complete recovery.
- Known hypersensitivity to any component of study treatments.
- Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug.
- Any history of hydroxychloroquine use (Plaquenil® and other brand names).
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- Fullerton, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Detroit, Michigan, United States
- Saint Cloud, Minnesota, United States
- New York, New York, United States
- Rochester, New York, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Tyler, Texas, United States
- Spokane, Washington, United States
- Tacoma, Washington, United States
- Milwaukee, Wisconsin, United States
- Garran, Australia Capital Territory, Australia
- Tweed Heads, New South Wales, Australia
- Kurralta Park, South Australia, Australia
- Heidelberg, Victoria, Australia
- Murdoch, Western Australia, Australia
- Klagenfurt, Carinthia, Austria
+ 61 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hot Springs, Arkansas, United States; Fullerton, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Detroit, Michigan, United States; Saint Cloud, Minnesota, United States and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.